Status:
RECRUITING
Clinical Investigation of Herbal Formulation and Its Efficacy in Polycystic Ovarian Syndrome
Lead Sponsor:
Jinnah Postgraduate Medical Centre
Conditions:
Polycystic Ovarian Syndrome (PCOS)
Herbal Medicine
Eligibility:
FEMALE
18-40 years
Phase:
PHASE1
Brief Summary
Polycystic Ovarian Syndrome (PCO) is a metabolic disorder that afflicts the women of childbearing age. An approximate of 5-10% women are the victim of this disorder. PCOS is a leading cause of inferti...
Detailed Description
Polycystic Ovarian Syndrome is a point of concern these days in female population around the world.The patients feel psychological and mentally unhealthy. PCO effects around 6- 14% of women worldwide....
Eligibility Criteria
Inclusion Criteria:
- Female subjects of reproductive age (18-40 years).
- Subjects with a diagnosis of polycystic ovary syndrome (PCOS) confirmed by clinician diagnostic criteria.
- Subjects with insulin resistance defined as HOMA-IR > 2.00.
Exclusion Criteria:
- Pregnant or lactating women.
- Subjects with known Cushing's syndrome.
- Subjects with late-onset congenital adrenal hyperplasia.
- Subjects with androgen-secreting tumors.
- Subjects with uncontrolled thyroid disease.
- Subjects with hyperprolactinemia.
- Subjects with diabetes mellitus.
- Subjects with uncontrolled hypertension.
- Subjects with other cardiovascular diseases.
- Subjects with acute or chronic infections.
- Subjects with any known malignancy.
- Subjects with impaired renal function (serum creatinine > 1.5 × ULN).
- Subjects with impaired liver function (serum ALT ≥ 2.5 × ULN).
Key Trial Info
Start Date :
February 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT07399535
Start Date
February 22 2025
End Date
March 1 2026
Last Update
February 10 2026
Active Locations (1)
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1
Jinnah Postgraduate Medical Centre
Karachi, Sindh, Pakistan